Questions

October 28, 2003

Holiday Inn, The Ballrooms, Two Montgomery Village
Avenue, Gaithersburg, MD

Topic:Clinical trial design in Diabetic Foot
Infections

QUESTIONS TO
THE COMMITTEE

1.How does one define a
“diabetic foot infection”?Please
include in your discussions the considerations of patients with cellulitis
without breaks in the skin versus patients with pre-existing breaks in the
skin.

2.In patients with a
pre-existing skin ulcer, how does one define infected versus non-infected
ulcers?

3.What is the most accurate
way to obtain microbiologic information in patients with diabetic foot
infections?

4.What are the considerations
for clinical trials for ruling out osteomyelitis in patients in trials of
diabetic foot infections?Please discuss
how to determine drug efficacy for the diabetic foot infection in the setting
of osteomyelitis and whether such patients should be considered clinical cures
or failures.

5.How does one define clinical
success or failure patients in a clinical trial of diabetic foot infections?